FDA's New Enforcement of 21 CFR Part 11

Instructor: Dr. Ludwig Huber
Product ID: 701672
Training Level: Advanced
  • Duration: 75 Min

recorded version

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Read Frequently Asked Questions

Learn FDA requirements for 21 CFR Part 11, understand how to implement with the help of SOPs and case studies.

Why Should You Attend:
Though FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations. Just in 2007/2010, there have been about 30 Warning Letters related to Part 11 compliance, some with disastrous consequences for inspected companies. It seems that 'enforcement discretion' as stated in the 2003 guidance is not applied any more. Also FDA's computer expert John Murray recommended at a conference to follow 21 CFR Part 820 also for drug companies. This seminar will give a good understanding of current and future FDA requirements for 21 CFR Part 11 and provide steps, examples and tools for cost-effective implementation. Attendees will receive SOP to define and document scope and control of part 11. Along with it 15 case studies containing step by step description and recommendation for part 11 requirements.

Areas Covered in the Seminar:

  • FDA's current inspection and enforcement practices.
  • FDA's current interpretation: learning from FDA guidance, and FDA conference presentations and discussions.
  • Learning from FDA inspection reports.
  • Part 11 and the new EU Annex 11: similarity and differences.
  • Strategy for cost-effective implementation of the 'new' Part 11:A six step plan.
  • Recommended changes to existing Part 11 programs to reduce costs.
  • Justification and documentation for the FDA and your management.
  • Going through case studies from laboratories, offices and manufacturing.
  • Preparing for Part 11 Inspections.


For easy implementation, attendees will receive
  • SOP: Define and Document Scope and Controls for Part 11
  • 15 Case Studies
  • All well documented with graphical workflow, step-by-step description, recommendations for Part 11 requirements and justifications for the FDA and your management

Who Will Benifit:

  • (Bio)Pharmaceutical Companies
  • Device manufacturers
  • Manufacturers of pharmaceutical starting material
  • Clinical Laboratories
  • Software developers
  • IT managers and system administrators
  • QA managers and personnel
  • Analysts and lab managers
  • Validation professionals
  • Training departments
  • Documentation department
  • Consultants

Instructor Profile:
Ludwig Huber , Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of , the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. For more information, visit Dr. Huber’s website: .

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